TriSalus Life Sciences Launches TriNav® XP Infusion System to Expand Options for Pressure-Enabled Drug Delivery™

WESTMINSTER, Colo.--(BUSINESS WIRE)--TriSalus Life Sciences, an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, is pleased to announce the launch of the TriNav^® XP Infusion System, the latest advancement in the company’s portfolio of pressure-enabled drug delivery systems designed to improve therapy delivery in varying vascular environments.

Building on the success of the TriNav platform, TriNav XP was engineered specifically for compatibility with larger embolic particles (beads up to and including 700 μm) while maintaining the performance and safety features that Interventional Radiologists require. TriNav XP is designed with a more flexible distal tip for improved trackability, is available in both 130 cm and 150 cm lengths, and is recommended for use in 1.5 mm to 3.5 mm vessels.

TriNav XP incorporates SmartValve^® Technology, which has been shown in multiple studies to more effectively deliver therapies deep within the target anatomy, while reducing non-target delivery to surrounding healthy tissues compared to delivery with a traditional microcatheter^1-3.

“At TriSalus, our goal is to empower physicians with tools that deliver therapy more effectively and consistently,” said Mary Szela, CEO and President of TriSalus Life Sciences. “The TriNav XP Infusion System extends the reach of our Pressure-Enabled Drug Delivery™ approach with our SmartValve Technology, giving clinicians greater flexibility to treat patients in a range of embolization procedures.”

For more about TriSalus Life Sciences, visit www.trisaluslifesci.com.

About TriSalus Life Sciences

TriSalus Life Sciences^® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s delivery systems employ its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to treat the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development. In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.

For more about TriSalus Life Sciences, visit www.trisaluslifesci.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby under the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “become,” “may,” “intend,” “will,” “expect,” “anticipate,” “believe” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding TriSalus’s business, the commercial potential of its TriNav Infusion System, TriSalus’s proprietary PEDD approach, the potential therapeutic benefits and commercial potential of Nelitolimod, and TriSalus’s technologies and other products in development. Such statements are subject to certain risks and uncertainties, including, but not limited to, those inherent in the process of developing and commercializing medical devices that are safe and effective for human use, discovering, developing and commercializing medicines that are safe and effective to use as human therapeutics, and the endeavor of building a business around such medical devices and medicines.

TriSalus’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although TriSalus’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by TriSalus. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning TriSalus’s products and programs are described in additional detail in TriSalus’s annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission (the "SEC") and available at the SEC's website (www.SEC.gov). These forward-looking statements are made as of the date of this press release, and TriSalus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

References

1. d’Abadie P, Walrand S, Goffette P, et al. Antireflux catheter improves tumor targeting in liver radioembolization with resin microspheres. Diagn Interv Radiol. 2021;27(6):768-773.

2. Titano JJ, Fischman AM, Cherian A, et al. End-hole versus microvalve infusion catheters in patients undergoing drug-eluting microspheres–TACE for solitary hepatocellular carcinoma tumors: a retrospective analysis. Cardiovasc Intervent Radiol. 2019;42(4):560-568.

3. Pasciak AS, McElmurray JH, Bourgeois AC, Heidel RE, Bradley YC. The impact of an antireflux catheter on target volume particulate distribution in liver-directed embolotherapy: a pilot study. J Vasc Interv Radiol. 2015;26(5):660-669.